Notice of Application - 2012
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Page 43863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18212]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application;
Cambrex Charles City, Inc.
Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal
Regulations (CFR), this is notice that on May 4, 2012, Cambrex Charles
City, Inc., 1205 11th Street, Charles City, Iowa 50616, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered as a bulk manufacturer of the following basic classes of
controlled substances:
| Drug |
Schedule |
| Gamma Hydroxybutyric Acid (2010) |
I |
| Amphetamine (1100) |
II |
| Lisdexamfetamine (1205) |
II |
| Methylphenidate (1724) |
II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) |
II |
| Phenylacetone (8501) |
II |
| Cocaine (9041) |
II |
| Codeine (9050) |
II |
| Oxycodone (9143) |
II |
| Hydromorphone (9150) |
II |
| Hydrocodone (9193) |
II |
| Methadone (9250) |
II |
| Dextropropoxyphene, bulk (non-dosage forms) (9273) |
II |
| Morphine (9300) |
II |
| Oripavine (9330) |
II |
| Thebaine (9333) |
II |
| Opium, raw (9600) |
II |
| Opium extracts (9610) |
II |
| Opium fluid extract (9620) |
II |
| Opium tincture (9630) |
II |
| Opium, powdered (9639) |
II |
| Opium, granulated (9640) |
II |
| Oxymorphone (9652) |
II |
| Noroxymorphone (9668) |
II |
| Poppy Straw Concentrate (9670) |
II |
| Alfentanil (9737) |
II |
| Remifentanil (9739) |
II |
| Sufentanil (9740) |
II |
| Fentanyl (9801) |
II |
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers, for dosage form development, for
clinical trials, and for use in stability qualification studies.
Any other such applicant, and any person who is presently
registered with DEA to manufacture such substances, may file comments
or objections to the issuance of the proposed registration pursuant to
21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than September 24, 2012.
Dated: July 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-18212 Filed 7-25-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
